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Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN (EU-TRAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652402
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Main objective: To design a precision risk stratification system that predicts individual risk of rejection

Condition or disease Intervention/treatment
Kidney Transplant Rejection Kidney Transplantation Risk Stratification Prognosis Procedure: kidney transplantation

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The EUropean TRAnsplantation and INnovation Consortium for Risk Stratification in Kidney Transplant Patients
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: kidney transplantation
    samples additional to the standard of care' (SOC)will be taken at each visit (Day 0, Month 3, Month12, clinical indication)
    Other Names:
    • Gene expression analysis in the biopsy
    • Non-HLA antibody analysis in the blood
    • Protein biomarker analysis in the blood
    • T and B cell analyses in the blood
    • mRNA in the blood


Primary Outcome Measures :
  1. Capacity of non-invasive biomarkers and intragraft gene expression profiles combined to standard of care data (HLA system, clinical and biological data) [ Time Frame: Day 0, Month 3, Month 12, clinical indication over 12 months ]
    Prognosis value of non-invasive biomarkers and intragraft gene expression profile changes combined to standard of care data changes (HLA system, clinical and biological data), to identify high versus low risk profiles of rejection as measured by DSA characteristics (Donor-Specific Antibody) by Luminex single antigen assay and non DSA characteristics by functional in vitro assay on endothelial targets, alloreactive T and B cells profiles by ELISPOT, blood mRNA expression by NanoString technologies and gene expression on DNA chips.


Secondary Outcome Measures :
  1. Correlation of blood biomarkers concentration with allograft rejection (rejection assessed by histopathology) [ Time Frame: Day 0, Month 3, Month12, clinical indication over 12 months ]
    Blood biomarkers measured: HLA and non-HLA DSA characteristics (by Luminex Single Antigen and functional in vitro assay on endothelial targets), alloreactive T and B cell profiles (by ELISPOT) and candidate gene profiles by NanoString technologies: AKR1C3, CD40, CTLA4, ID3, MZB1, TCL1A, TRIB1, TLR4 TUBA4A, WHAZ, CD3E, CD8A, CD4, MS4A1, FOXP3, GZMB, ENTPD1, POU2AAF1, POU2F1, CD9, IL7R, BLK, MMP9, CXCL9, CXCL10, CXCL11, UPK1A, TGFB1, IL2RA, PRF1, TIMP1, PAI1, FN1, TIGIT and 4 reference genes: HPRT1, B2M, GAPDH and ACTB

  2. Correlation of blood biomarker concentrations with allograft function (function measured by the Glomerular Filtration Rate (GFR)). [ Time Frame: Day 0, Month 3, Month12, clinical indication over 12 months ]
    Blood biomarkers measured: HLA and non-HLA DSA characteristics (by Luminex Single Antigen and functional in vitro assay on endothelial targets), alloreactive T and B cell profiles (by ELISPOT) and candidate gene profiles by NanoString technologies: AKR1C3, CD40, CTLA4, ID3, MZB1, TCL1A, TRIB1, TLR4 TUBA4A, WHAZ, CD3E, CD8A, CD4, MS4A1, FOXP3, GZMB, ENTPD1, POU2AAF1, POU2F1, CD9, IL7R, BLK, MMP9, CXCL9, CXCL10, CXCL11, UPK1A, TGFB1, IL2RA, PRF1, TIMP1, PAI1, FN1, TIGIT and 4 reference genes: HPRT1, B2M, GAPDH and ACTB

  3. Assessment of changes in biomarker levels in serial measurements and association with allograft function (function measured by the GFR) [ Time Frame: Day 0, Month 3, Month12, clinical indication over 12 months ]
    Blood biomarkers measured: HLA and non-HLA DSA characteristics (by Luminex Single Antigen and functional in vitro assay on endothelial targets), alloreactive T and B cell profiles (by ELISPOT) and candidate gene profiles by NanoString technologies: AKR1C3, CD40, CTLA4, ID3, MZB1, TCL1A, TRIB1, TLR4 TUBA4A, WHAZ, CD3E, CD8A, CD4, MS4A1, FOXP3, GZMB, ENTPD1, POU2AAF1, POU2F1, CD9, IL7R, BLK, MMP9, CXCL9, CXCL10, CXCL11, UPK1A, TGFB1, IL2RA, PRF1, TIMP1, PAI1, FN1, TIGIT and 4 reference genes: HPRT1, B2M, GAPDH and ACTB Biomarkers measured in the biopsy: pangenomic approach of gene expression profiles using Affymetrix DNA chips and comparing gene expression in low- and high-risk patients

  4. Correlation of gene expression in kidney allografts with allograft rejection (rejection assessed by histopathology) [ Time Frame: Day 0, Month 3, Month 12, clinical indication over 12 months ]
    Biomarkers measured in the biopsy: pangenomic approach of gene expression profiles using Affymetrix DNA chips and comparing gene expression in low- and high-risk patients

  5. Gene expression related risk stratification of response to treatment in kidney allograft rejection (rejection assessed by histopathology) [ Time Frame: Day 0, Month 3, Month12, clinical indication over 12 months ]
    Blood biomarkers measured: Candidate gene profiles by NanoString technologies: AKR1C3, CD40, CTLA4, ID3, MZB1, TCL1A, TRIB1, TLR4 TUBA4A, WHAZ, CD3E, CD8A, CD4, MS4A1, FOXP3, GZMB, ENTPD1, POU2AAF1, POU2F1, CD9, IL7R, BLK, MMP9, CXCL9, CXCL10, CXCL11, UPK1A, TGFB1, IL2RA, PRF1, TIMP1, PAI1, FN1, TIGIT and 4 reference genes: HPRT1, B2M, GAPDH and ACTB Biomarkers measured in the biopsy: pangenomic approach of gene expression profiles using Affymetrix DNA chips and comparing gene expression in low- and high-risk patients

  6. Assessment of the changes of patient's well-being across time and centres [ Time Frame: Day 0, Month 3, Month12, clinical indication over 12 months ]
    Assessment of the changes of patient's well-being across time and centres using the results of a self health-questionnaire filled in by each patient at each time point. All items are measured on a scale of 1 to 3. The first 3 items measure mobility, self-care and performance of usual activities, with higher values indicating lower mobility and unability to take care of one's self or to perform usual activities, respectively. The 4th item measures pain and discomfort, with higher values indicating extreme pain or discomfort. The last item measures anxiety and depression, with higher values indicating extreme anxiety or depression. A general self-reported health state measures patient's opinion about his/her own health on a scale of 0 to 100, with a 0 score as the worst state and 100 as the best state.


Biospecimen Retention:   Samples With DNA
blood samples, kidney biopsy samples for these analysis : Transcriptomics analysis Characteristics of anti HLA DSA analysis on endothelial targets Non-HLA antibodies analysis Omics blood analysis T and B cell analyses (ELISPOT) Blood mRNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New kidney transplants patients
Criteria

Inclusion Criteria:

  • Men and women, Age ≥ 18 years old at the time of transplantation.
  • Patients receiving a living or deceased donor kidney allograft.
  • Patients who signed the informed consent form and willing to comply with study procedures.
  • Female patients of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and must be practicing an effective, reliable and medically approved contraceptive regimen

Exclusion Criteria:

  • History of multi-organ transplant (interference with rejection natural history).
  • Participant is unable or unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native language speaker).
  • Vulnerable participants (minors, protected adults, legally detained)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652402


Contacts
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Contact: Carmen Lefaucheur, Pr +33 1 42 49 49 49 carmenlefaucheur4@gmail.com
Contact: Philippe Gallula + 33 1 57 27 83 17 philippe.gallula@aphp.fr

Locations
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France
Hopital Saint Louis Recruiting
Paris, Ile De France, France, 75010
Contact: lefaucheur Carmen, Pr    06 76 69 49 46 ext 33    carmenlefaucheur4@gmail.com   
Hôpital du Kremlin Bicêtre Recruiting
Le Kremlin-Bicêtre, Paris, France, 94270
Contact: Antoine DURRBACH       antoine.durrbach@aphp.fr   
CHU Nantes Recruiting
Nantes, France, 44093
Contact: Magali GIRAL       magali.giral@chu-nantes.fr   
Hôpital Necker Recruiting
Paris, France, 75015
Contact: Christophe Legendre       christophe.legendre@aphp.fr   
Germany
Hospital La Charité Recruiting
Berlin-Mitte, Berlin, Germany, 10117
Contact: Klemens BUDDE       klemens.budde@charite.de   
Hospital La Charité Campus Virchow Recruiting
Berlin, Germany, 10117
Contact: Fabian Halleck       fabian.halleck@charite.de   
Spain
Hospital Bellvitge Recruiting
Barcelona, Spain, 08907
Hospital Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08907
Contact: Daniel SERON       dseron@vhebron.net   
Switzerland
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 4 CH 1211
Contact: Jean Villard       jean.villard@hcuge.ch   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Alexandre Loupy, Pr Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03652402    
Other Study ID Numbers: K170203J
IDRCB 2018-A00733-52 ( Other Identifier: Assistance Publique Hôpitaux de Paris )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Kidney
Allogenic transplantation
Cohort study
Rejection
Biomarkers
Response to treatment
Integrative medicine